Metabolomic Study of All-age Cardiomyopathy (MAC)
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|ClinicalTrials.gov Identifier: NCT03061994|
Recruitment Status : Unknown
Verified March 2017 by Beijing Institute of Heart, Lung and Blood Vessel Diseases.
Recruitment status was: Recruiting
First Posted : February 23, 2017
Last Update Posted : May 30, 2017
|Condition or disease|
|Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy Left Ventricular Non-compaction Restrictive Cardiomyopathy|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Metabolomic Study of Patients With Cardiomyopathy in China|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
Children(older than 18 years old) are diagnosed as cardiomyopathy by three cardiologists and recruited in pediatric heart center,Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.
Adults are diagnosed as cardiomyopathy by three cardiologists and recruited in the department of cardiology ,Beijing Anzhen Hospital.
Healthy children and adults are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination.
- Result of echocardiography [ Time Frame: three year ]The whole results of echocardiography report will be recorded. The indicates whi ch can reflect cardiac function including Left ventricular ejection fraction, left ventricular end diastolic diameter, E/A ratio of bicuspid valve will be used to calculate the association with metabolites.
- Cardiovascular death [ Time Frame: One year/Three year ]The data is collected during follow-up visit at 1/3 years after discharge
- Re-hospitalization [ Time Frame: One year/Three year ]patients are hospitalized due to heart failure with decreasing left ventricular ejection fraction (LVEF) or worsen symptoms. The data is collected during follow-up visit at 1/3 years after discharge
- Heart transplantation [ Time Frame: One year/Three year ]patients are hospitalized due to heart failure.The data is collected during follow-up visit at 1/3 years after discharge
- malignant arrythmia [ Time Frame: One year/Three year ]Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.
- Worsening heart failure [ Time Frame: These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting ]Worsen heart failure is defined as decreased ejection fraction(left ventricular ejection fraction decreased over 10%), left ventricular ejection fraction <45% and enlarged heart size measured by echocardiography and changing level of New York Heart Association (NYHA) Functional Classification.And patients who undergo left ventricular assist device (LVAD) will also be included.The data is collected during follow-up visit at 3/6/9/12/36 months after enrollment.
- Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of plasma sample [ Time Frame: The data is collected from lab in an average of 3 month after the sample recruiting ]The results of metabolomics will be measured by mass spectrometry, including lipids, sugars and amino acids. All of metabolites will be quantitative(unit:mol/L). Identification of molecules via Human Metabolites Database will be reported online.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061994
|Contact: Jie Du, PhDfirstname.lastname@example.org|
|Contact: Hongzhao Youemail@example.com|
|Study Director:||Yulin Li, PhD||Beijing anzhen hospital affiliated to capital medical university|
|Study Director:||Yongqiang Lai, MD||Beijing anzhen hospital affiliated to capital medical university|